Big Events in Biosimilars

Big Events in Biosimilars

Sandoz-Biocon: Significant Biosimilar Deal

Make no mistake.  Biosimilars are here.  Two events in the news recently.  First, a major deal between Novartis subsidiary Sandoz and Bangalore, India-based biosimilar player Biocon confirms the rise of these close copies of biodrug major brands. According to media reports, the two companies will develop and bring to market “multiple biosimilars in immunology and oncology” that will “address the next wave of biosimilar opportunities globally.” Kalorama estimates that the global market for biosimilar products has grown to be worth almost $4.4 billion according to its new report, Biosimilars: Global Market, Trends and Competitor Analysis.

That's growth from $200 million in 2008.  And it’s a signal that it’s time for pharmaceutical companies to take biosimilars seriously, if they weren’t before.

Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biosimilars are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics. The worldwide prescription generic drug market has stood the test of time and has endured numerous growing pains. However, it has evolved into a formidable and important participant in the complex world of health care. Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process are facilitating bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years.

Biocon Ltd. is an Indian-based pharmaceutical company that was founded by Kiran Mazumdar-Shaw in 1978. The company is involved in the manufacture, processing, distilling, formulating, and marketing of biotechnology products. Today, Biocon is one of India’s premier biotechnology companies, along with its subsidiary companies, Syngene International and Clinigene International. The company launched its flagship product, Insugen, using Pichia expression, in 2004 and India’s first indigenously developed monoclonal antibody for head and neck cancer, BioMAb EGFR. The company has eight subsidiaries and two step down subsidiaries. Biocon FZ, LLC is a wholly owned subsidiary that was incorporated in June 2015. Biocon Biologics Limited was incorporated in the UK in 2016. Biocon Pharma was incorporated in 2015 in the United States.

In 2013, the companies received approval from the Indian Regulatory body for trastuzumab for treating breast cancer. In 2015, Biocon and Mylan announced that PEG-GCSF, adalimumab, and glargine are in Phase III. Glargine has completed the Phase III study.
In 2016, Insulin Glargine received approval and was launched in Japan. The company also received its first generic formulation approval in the EU for rosuvastatin launched in 2017.
As of 2017, the company’s global biosimilar portfolio includes:

 Trastuzumab (Herceptin) Phase III completed FDA review

 Bevacizumab (Avastin) Phase I global

 Adalimumab (Humira) Phase III

 Pegfilgrastim (Neulasta) Phase III completed FDA and EU filings

 Filgrastim (Neupogen) Preclinical

 Etanercept (Enbrel) Preclinical

Biosimilar for Avastin Earns EU Approval

At the same time, news came that the European Commission has approved the bevacizumab (Avastin) biosimilar ABP 215 (bevacizumab-awwb; MVASI), for the treatment of patients across several tumor types. The tumor types included:

  • Metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemotherapy;
  • Metastatic breast cancer, in combination with paclitaxel;
  • Unresectable advanced, metastatic or recurrent non-squamous non–small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy;
  • Unresectable advanced, metastatic or recurrent nonsquamous NSCLC, in combination with erlotinib;
  • Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a;
  • Advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin
  • • Persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan.

  In September, the FDA approved ABP-215 as the first biosimilar indicated for the treatment of cancer in the United States. The agent is indicated for the treatment of colorectal, lung, brain, kidney, and cervical cancers in adult patients. The information the FDA reviewed included data from a pair of studies: the 3-arm, single-dose PK study 20110216 that compared ABP-215 with US- and EU-approved bevacizumab, and a comparative clinical study, 210120265.
The second study compared ABP-215 and EU-approved bevacizumab in patients with advanced/metastatic NSCLC to support the demonstration of no clinically meaningful differences in terms of response, safety, purity, and potency.

These are the two newsmakers this week, but there are scores of other companies in the market – Kalorama’s Biosimilars: Global Market and Trend Analysis contains information on scores of companies in biosimilars, which drugs may be most affected, and what companies are doing.